A General Strategy to Compare Stability Slopes of Biologics Using Short-Term data from Post-Change Batches Versus Long-Term Data from Pre-Change Batches [0.03%]
一种通用策略：使用变更批次的短期数据与变更前批次的长期数据比较生物药稳定性斜率
Jos Weusten,Ji Young Kim
Jos Weusten
Objective: Pharmaceutical products are under constant development and improvements are continuously made. Implementing a change can have impact on the stability of the product. Comparing stability slopes of post-change ba...
Zijian Wang,Chenguang Wang,Tianxiang Gao et al.
Zijian Wang et al.
Purposes: The tabletability flip phenomenon (TFP), where an active pharmaceutical ingredient (API) with poorer tabletability exhibits better tabletability when formulated with excipients, has been well documented in direc...
Multi-Target Anticoagulant Regulation by Peptides from Medicinal Leeches: A Unique Natural Strategy against Thrombosis [0.03%]
药用蚯蚓肽的多靶标抗凝调节作用：一种独特的抗血栓形成策略
Feng Shi,Qingmei Hu,Yiquan Lin et al.
Feng Shi et al.
Background: Thrombotic diseases remain a major global health burden. Current anticoagulants are often limited by bleeding risks and narrow therapeutic windows, largely due to their single-target mechanisms. In contrast, m...
A Novel Non-Aqueous Emulsification Platform to Fabricate Polymeric Microspheres for Sustained Delivery of Biologics [0.03%]
一种新型非水相乳化平台技术，用于生物制剂缓释聚合物微球的规模化制备研究
Nishant S Kulkarni,Roshan James,Aishwarya Saraswat et al.
Nishant S Kulkarni et al.
Objective: Polymeric microspheres (MS) have been developed with moderate success using aqueous emulsification (AqE) for small molecules and peptides with a few approved products. AqE faces a challenge to achieve optimal e...
Intracerebral Distribution of Drugs with Diverse Blood-brain Barrier Transport Characteristics: In vivo Analysis using Brain Microdialysis in Cynomolgus Monkeys [0.03%]
具有不同血脑屏障转运特性的药物在大脑内的分布：采用食蟹猴脑微透析进行的体内分析研究
Takuya Fujita,Yukari Kamikozawa,Makoto Ozawa et al.
Takuya Fujita et al.
Objective: The purpose of this study is to analyze the impact of the blood-brain barrier (BBB) and blood-cerebrospinal fluid barrier (BCSFB) transport characteristics of drugs on their intracerebral distribution in male c...
Deep Dive into Generic Drug Applications to Seek Harmonization of Bioequivalence Criteria for Narrow Therapeutic Index Drugs [0.03%]
以窄治疗指数药物 bioequivalence 标准的国际协调为目标而深入探讨仿制药的申报资料
Mirette Mina,Zhen Zhang,Wanjie Sun et al.
Mirette Mina et al.
Purpose: U.S. Food and Drug Administration (FDA) recommends reference scaled limits and variability comparison for bioequivalence (BE) demonstration of narrow therapeutic (NTI) drugs while most other regulatory agencies a...
Physicochemical Differences Observed in Photostability Studies of Lyophilized, Reconstituted, and Diluted Somatropin [0.03%]
冷冻干燥生长激素的光稳定性研究中的物理化学差异
Jordan D Pritts,Uriel Ortega-Rodriguez,V Ashutosh Rao
Jordan D Pritts
Background: While photostability testing conditions for biologics are often based on small molecule standards, the unique characteristics of proteins necessitate a deeper understanding of appropriate testing and controls....
Development, Optimization, and Evaluation of Nano Self-Emulsifying Drug Delivery System Formulation Platform for Oral Bioavailability Enhancement of Sulfasalazine and Disulfiram in Lung Cancer Chemoprevention [0.03%]
口服自给纳米 self-emulsifying drug delivery system 的开发，优化及评估：用于肺癌化学预防中的柳氮磺胺吡啶和双硫仑生物利用度增强
Preshita Desai,Katherine Bang,Mohammed Riaz Hasan Chowdhury et al.
Preshita Desai et al.
Objective: Lung cancer chemoprevention modalities are gaining wide attention as it is the second most diagnosed cancer type and the leading cause of cancer-related deaths. Our previous studies reported unique lung cancer ...
M N V Ravi Kumar
M N V Ravi Kumar
How Breathing Interruptions Influence pMDI Aerosol Delivery: A CFD Study in a Realistic Airway [0.03%]
呼吸中断对pMDI气溶胶递送影响的计算流体动力学研究： realistic airway中的研究
Mahsa Jahed,Janusz Kozinski,Leila Pakzad
Mahsa Jahed
Objective: The effectiveness of pressurized metered-dose inhalers (pMDIs) relies on correct inhalation technique. While prior studies investigated idealized breathing, the impact of real-life irregularities remains less u...